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Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Key result

Water solubility:

< 0.051 mg/L

Conc. based on:

test mat.

Loading of aqueous phase:

73 mg/L

Incubation duration:

24 h

Temp.:

20 °C

pH:

7

Details on results:

As no test item was detected in the majority of the samples, and where test item was detected, the response was significantly below that of the lowest calibration standard, the result has been reported as a limit value. The Iimit value used is the level at which satisfactory recovery was demonstrated for the sample analysis procedure, i.e. 5.06 x 10-5 g/L.

The preliminary water solubility test indicated that the column elution method should have been performed as the solubility was less than 1x10^-2g/L. However, due to the extremely low water solubility of the test item, a large volume of sample was required for the analysis. This made determination by the column elution method impractical due to the extremely large reservoir volume which would be required to facilitate multiple samples to be taken. Therefore the flask method was used as this allowed for larger sample volumes to be taken for analysis.

The concentration (g/L) of test item in the sample solutions is shown in the following table:

Sample Number	Time Shaken at ~ 30 °C (hours)	Time Equilibrated at  20 °C (hours)	Concentration (g/L)	Solution pH
1A 1B	24	24	< 5.06 X 10^-5	6.75
			< 5.06 X 10^-5
2A 2B	48	24	< 5.06 X 10^-5	5.91
			< 5.06 X 10^-5
3A 3B	72	24	< 5.06 X 10^-5	6.35
			< 5.06 X 10^-5

Conclusions:

According the TG OECD 105 and GLP study, the water solubility of the test material is less than 5.06 x 10-5 g/L of solution at 20.0 ± 0.5 °C.

Executive summary:

An experimental study was performed in accordance with GLP and TG OECD 105 to determine the water solubility of the test item. The solubility is less than 0.0506 mg/L at 20°C, and the substance is therefore considered insoluble in water.

Description of key information

Key Study:

In an OECD 105 study, conducted according to GLP, the water solubility of the test material is less than 0.0506 mg/L, and is therefore considered insoluble in water.

 

Key value for chemical safety assessment

Water solubility:

0.051 mg/L

at the temperature of:

20 °C

Additional information

Supporting Studies:

In an EU Method A.6 study, not conducted according to GLP, the water solubility of the structurally similar read across substance is less than 0.01 mg/L.

In an EU Method A.6 study, not conducted according to GLP, the water solubility of the structurally similar read across substance is less than 0.05 mg/L.